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Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.

ABSTRACT: It is crucial that randomized controlled trials (RCTs) on the management of coronavirus disease 2019 (COVID-19) evaluate the outcomes that are critical to patients and clinicians, to facilitate relevance, interpretability, and comparability. This methodological systematic review describes the outcomes evaluated in 415 RCTs on the management of COVID-19, that were registered with ClinicalTrials.gov, by 5 May 2020, and the instruments used to measure these outcomes. Significant heterogeneity was observed in the selection of outcomes and instruments. Mortality, adverse events and treatment success or failure are only evaluated in 64.4%, 48.4% and 43% of the included studies, respectively, while other outcomes are selected less often. Studies focusing on more severe presentations (hospitalized patients or requiring intensive care) most frequently evaluate mortality (72.5%) and adverse events (55.6%), while hospital admission (50.8%) and viral detection/load (55.6%) are most frequently assessed in the community setting. Outcome measurement instruments are poorly reported and heterogeneous. Follow-up does not exceed one month in 64.3% of these earlier trials, and long-term COVID-19 burden is rarely assessed. The methodological issues identified could delay the introduction of potentially life-saving treatments in clinical practice. Our findings demonstrate the need for greater consistency, to enable decision makers to compare and contrast studies.

SUBMITTER: Mathioudakis AG

PROVIDER: S-EPMC7765224 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.

Mathioudakis Alexander G AG Fally Markus M Hashad Rola R Kouta Ahmed A Hadi Ali Sina AS Knight Sean Blandin SB Bakerly Nawar Diar ND Singh Dave D Williamson Paula R PR Felton Tim T Vestbo Jørgen J

Life (Basel, Switzerland) 20201215 12

It is crucial that randomized controlled trials (RCTs) on the management of coronavirus disease 2019 (COVID-19) evaluate the outcomes that are critical to patients and clinicians, to facilitate relevance, interpretability, and comparability. This methodological systematic review describes the outcomes evaluated in 415 RCTs on the management of COVID-19, that were registered with ClinicalTrials.gov, by 5 May 2020, and the instruments used to measure these outcomes. Significant heterogeneity was o ...[more]

PMID: 33333777

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Project description:BACKGROUND:The accessibility of services within community pharmacies provides an ideal opportunity to manage minor ailments, yet over £1.1 billion is spent by the National Health Service (NHS) in the United Kingdom (UK) in managing minor ailments in high cost settings. There is a need to review the evidence base around clinical effectiveness of pharmacy-based management of minor ailments since the absence of such may lead to under-utilisation of pharmacy services and non-implementation of available pharmacy service models. This study aimed to systematically review the methodological approaches used to assess clinical outcomes of pharmacy-based management of minor ailments in the research literature. METHODS:A systematic review was conducted to identify relevant literature using the following databases: Medline, EMBASE, CINAHL, IPA, CRD, CDSR, and Google Scholar from publication year 2000 onwards. Studies were included if they evaluated clinical outcomes of pharmacy-based management of any minor ailments, with or without a comparator setting such as Emergency Departments (EDs) or general practices. Screening and selection of titles, abstracts and full texts followed by data extraction and quality assessment (QA) was conducted. Paired researchers, from the team, reviewed papers using a protocol based on the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). QA was undertaken using the Critical Appraisal Skills Programme (CASP). Reporting was conducted in accordance with PRISMA checklist and statements. RESULTS:A total of 19 studies were included. The majority of studies were observational, conducted in community pharmacies, and did not use a comparator participant group nor a comparator setting. Interventions included counselling, medicines supply and provision of advice on the management of minor ailments. One study used the randomised controlled trial (RCT) design with majority of the study utilising observational design. A range of clinical outcomes including symptom severity, pattern, resolution, and quality of life were reported. Methods used for the assessment of clinical outcomes were, overall, poorly reported. This included a lack of information on the development and validation of the data collection tools and the timing of baseline and follow-up data collection. Adverse clinical outcomes data were collected by only seven studies. CONCLUSIONS:Currently, there are methodological limitations in the studies that have sought to assess clinical outcomes of pharmacy-based management of minor ailments. Such lack of high quality evidence may contribute to failings to shift care from high cost settings, such as EDs and general practices. Generation of high quality evidence is likely to influence public choices when seeking care for minor ailments. There is scope for development of a core outcomes set specific to minor ailments management and development of a validated methodology for measuring such outcomes in a research study.

Dataset Information

Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.

Publications

Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.

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